Contact Radiotherapy for Rectal Cancer (NCT06501053) | Clinical Trial Compass
RecruitingNot Applicable
Contact Radiotherapy for Rectal Cancer
Sweden110 participantsStarted 2025-03-03
Plain-language summary
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adenocarcinoma of the rectum classified as:
* cT1-cT3ab, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (\<= 3 nodes \< 8mm diameter), M0
* Performance status (ECOG) 0-1
* Operable patient
* Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
* 18 years or above
* No comorbidity preventing treatment
* Patient having read the information note and having signed the informed consent
* Follow-up possible
Exclusion Criteria:
* Inoperable patient
* T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
* Distance from the lower tumor border to the anal verge \>10 cm
* N2-status at diagnosis or N1 with any node\>= 8 mm diameter
* Patient presenting with metastasis at diagnosis (M1)
* Previous pelvic irradiation
* Tumor with extramural vascular invasion
* Poorly differentiated tumor
* Simultaneous progressive cancer
* Tumor invading external anal sphincter or growth within 1 mm of the levator
* Tumor within 1 mm from MRF (mesorectal fascia)
* Patient unable to receive CXB or CRT
* Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
* Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol
* Concurrent enrolment in another clinical trial u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.